HOLLAND & BARRETT ST. JOHNS WORT CAPSULES

Transcript

PATIENT INFORMATION LEAFLET
St. John’s Wort Capsules
St. John’s Wort Extract 142mg
Important Notes
u Please read this leaflet carefully before you use this
product because it contains important information
u Keep this leaflet; you may need to read it again
u Seek professional advice if you need more
information
u Please tell a Doctor or a qualified Healthcare
Practitioner if your symptoms worsen or do not
improve after 6 weeks of taking this product
u Please tell a Doctor, Pharmacist or a qualified
Healthcare Practitioner if you suffer from side
effects not listed in this leaflet or if any of the
side effects become serious
In this leaflet
1 What this product is and what it is used for
2 Before you take this product
3 How to take this product
4 Possible side effects
5 How to store this product
6 Further information
1 - What this product is and what
it is used for
This product contains St. John’s Wort extract. It is a
traditional herbal medicinal product used to relieve
the symptoms of slightly low mood and mild
anxiety, based on traditional use only.
2 - Before you take this product
Do not take this product if you are:
u Under 18 years of age
u About to undergo surgery
u Allergic to any of the ingredients (see section
6 of this leaflet)
u Pregnant or breastfeeding
u Having UV light treatment (phototherapy) for
any condition
u Exceptionally sensitive to sunlight on your skin
(photosensitive)
u Suffering from depression
Symptoms of depression include feelings of
helplessness and hopelessness, loss of interest in
daily activities, changes in appetite or weight,
changes in sleeping patterns or habits, loss of
energy and difficulty in concentrating.
If your Doctor has told you that you are suffering
from depression do not use this product.
If you think you may be suffering from depression,
tell your Doctor before taking this product.

St John’s Wort can affect the way some medicines
work and reduce their effectiveness. Medicines that
can be affected by St. John’s Wort include
prescription medicines and those that you may have
bought yourself without a prescription.
Do not take St. John’s Wort if you are using any of
the following medicines:
All hormonal contraceptives - The birth control
‘Pill’, emergency contraception, hormonal implants,
creams, patches, intra-uterine devices with
hormones
All medicines for depression/anxiety Amitriptyline, clomipramine, moclobemide,
citalopram, fluoxetine, fluvoxamine, paroxetine,
sertraline, duloxetine, venlafaxine
All hormonal replacement therapy (HRT)
treatments - HRT tablets, patches, gels, vaginal rings
All medicines for thinning the blood
(anticoagulants) - Warfarin, acenocoumarol
All medicines for epilepsy - Carbamazepine,
phenobarbitone, phenytoin, primidone, sodium
valproate
All immunosuppressant medicines - Ciclosporin,
tacrolimus
All medicines for HIV infections - Amprenavir,
atazanavir, darunavir, fosamprenavir, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir,
efavirenz, nevirapine, delavirdine
Some medicines for cholesterol - Simvastatin,
atorvastatin
Some medicines for cancer - Irinotecan, dasatinib,
erlotinib, imatinib, sorafenib, sunitinib, etoposide,
mitotane
Some medicines for heart disease - Digoxin,
ivabradine, amiodarone
Some medicines for migraine - Almotriptan,
eletriptan, frovatriptan, naratriptan, rizatriptan,
sumatriptan, zolmitriptan
Some medicines for high blood pressure Amlodipine, nifedipine, verapamil, felodipine
A medicine for regulating mood - Lithium
A thyroid hormone - Thyroxine
St. John’s Wort may also affect the following
medicines. Do not take this product with these
medicines unless a Doctor has said it is safe to do so:
u Anaesthetics/pre-operative medicines:
Fentanyl, propofol, sevoflurane, midazolam
u Analgesics: Tramadol
u Antibiotics: Erythromycin, clarithromycin,
telithromycin
u Antifungals: Itraconazole, voriconazole
u Antimalarials: Artemether, lumefantrine
u Anti-Parkinson’s: Rasagiline
u Antipsychotics: Aripiprazole
u Anxiolytics: Buspirone

More information on back panel

u Treatment of post-operative vomiting: Aprepitant
u Barbiturates: Butobarbital, phenobarbital
u CNS Stimulants: Methyl phenidate
u Hormone antagonists: Exemestane
u Diuretics: Eplerenone
u Proton pump inhibitors: Lansoprazole, omeprazole
u Bronchodilator: Theophylline
u Antidiabetic medicine: Gliclazide
While you are taking this product:
u Avoid excessive sunbathing or use of
sunbeds/solariums
u Stop using it at least 10 days prior to undergoing
any surgery
Driving and operating machinery
In rare cases St. John’s Wort may make you feel dizzy or
sleepy. If affected do not drive or operate machinery.
3 - How to take this product
For oral use only.
For adults and elderly: Take 1 capsule 3 times daily.
Swallow the whole capsule with water.
Do not exceed the stated dose.
If you take too much of the product (overdose):
speak to a Doctor or a qualified Healthcare
Practitioner immediately and take this leaflet and
bottle with you.
If you forget to take this product: Do not take a
double dose to make up for the missed dose(s).
Continue to take your usual dose at the usual time.
It does not matter if you have missed a dose.
Duration of use: If symptoms worsen or do not
improve after 6 weeks, or if any of the side effects
become serious or if any side effects not mentioned
in the leaflet occur, speak to a Doctor, Pharmacist or
a qualified Healthcare Practitioner.
4 - Possible side effects
Like all medicines, this product can have side effects.
The following side effects have been reported:
u Gastrointestinal disorders such as indigestion, loss
of appetite, nausea, diarrhoea and constipation.
u Fatigue and restlessness.
u Allergic skin reactions such as rash, hives or
itching of the skin. If you experience allergic
skin reactions, stop taking the product and
consult your doctor.
u Sunburn-like reactions on skin exposed to
strong sunlight or strong ultra-violet (UV)
irradiation e.g. solarium, particularly in fair
skinned individuals.
Other side effects that have been reported include
headaches, nerve pain or tingling, anxiety, dizziness
and mania.
If any of the above side effects become serious or if
other side effects not mentioned above occur, a
Doctor or Pharmacist should be consulted.

5 - How to store this product
u Keep the capsules in the bottle until it is time to
take them
u Do not take the capsules after the expiry date
(see outer label). The expiry date refers to the
last day of the month
u Do not store above 25ºC. Store in the original
packaging
u Keep the bottle tightly closed
u Keep the capsules out of sight and reach of
children
6 - Further information
About this product: This product is a traditional
herbal medicinal product containing St. John’s Wort
extract. Each hard capsule contains 142mg of
extract (as dry extract) from St. John’s Wort aerial
parts (Hypericum perforatum L.) (equivalent to
711mg-995mg of St. John’s Wort). Extraction
solvent: Ethanol 60% v/v. This product also
contains the following inactive (excipient)
ingredients: Microcrystalline cellulose, Magnesium
stearate, Silica colloidal hydrated. Excipients in the
extract: Maltodextrin, Silica colloidal anhydrous.
Capsule shell: Hypromellose, Titanium dioxide
(E 171). Each bottle contains 50 or 100 white, hard,
two piece capsules with green/brown powder.
THR 21710/0002
Traditional Herbal Registration Holder
NBTY Europe Limited
Samuel Ryder House, Barling Way, Nuneaton,
Warwickshire, CV10 7RH, United Kingdom
Manufacturer
NBTY Europe Limited
Vitality House, Sixth Avenue, Centrum 100, Burton-on-Trent,
Staffordshire, DE14 2WP, United Kingdom
If you would like further information about this product,
please contact:
NBTY Europe Limited
Regulatory Services Department
Samuel Ryder House
Barling Way
Nuneaton
Warwickshire, CV10 7RH
United Kingdom
Is this leaflet hard to see or read? Contact us on:
Telephone: +44 (0) 2476 215 400
Fax: +44 (0) 2476 215 452
Email: customerservices@NBTYeurope.com
You can help to make medicines safer by reporting any
side effects to the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Alternatively you can get a paper Yellow Card form
from your GP’s surgery or pharmacy,
or call freephone 0808 100 3352
This leaflet was prepared on: 23/08/2011
BM509-000 00A I38088-000

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